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The CLASP III TR CED Study
Sponsor: Edwards Lifesciences
Summary
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system.
Official title: Edwards PASCAL Transcatheter Tricuspid Valve Repair System Coverage With Evidence Development Study (The CLASP III TR CED Study)
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2350
Start Date
2026-10-15
Completion Date
2033-10-31
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
PASCAL Precision system Treated
Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system.
Medicare Eligible Untreated Patients
Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention.
Locations (1)
Edwards Lifesciences
Irvine, California, United States